MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPER DBL-ACT 5MM; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8360-10

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That a prestige atra grasper dbl-act 5mm (part # 8360-10) was in need of repair.According to the complainant, the distal tip separated from the shaft.The failure was observed in sterile processing.The complaint device was returned to the manufacturer for evaluation.No patient involvement.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: aesculap inc.Previously reported that a supplier corrective action request (scar) was initiated due to an adverse trend observed for devices exhibiting failure at the thumb-loop assembly joint.The supplier evaluated the malfunction which revealed an issue with the push rod fixture.As a result of their findings, the push rod fixture was redesigned to increase the clearance, which ensured that the fixture appropriately stressed the entirety of the soldering joint.Upon implementing the new fixture, the supplier tested returned non-conforming samples, and verified that the soldering no longer hung up on the new fixture, as had been observed on the previous one the complaint device was returned to the manufacturer for physical evaluation.A visual examination was performed which confirmed a separation of the distal tip.No visible defects to the proximal weld were observed.An investigation of the device manufacturing records was conducted by the manufacturer for the lot # of the device in question.No non-conformances were reported.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Additionally, historical scrap rates were reviewed with no increase observed in scrap related to the complaint issue.In addition to the redesign of the soldering fixture, the supplier reviewed the work instruction for the torch soldering operation and identified improvement opportunities.The original work instruction was used to better define the soldering process with a more focused emphasis on the following: equipment startup and shutoff operations, clear imagery of acceptable soldered subassemblies, and clarified cleaning operations for components prior to soldering.A second dedicated work instruction was implemented to better define the attribute inspection criteria for the brazing process used for the solder between the thumb loop and rotator block.The investigation into the cause of the reported problem was able to confirm the failure mode of a distal tip separation.This event likely occurred due to inadequacies in the defined production process which limited the device performance.Therefore, the most probable root cause is considered to be manufacturing related.In addition to a supplier corrective action request (scar) being initiated, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.

Event Description

No update needed.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11667884
• MDR Text Key: 262726309
• Report Number: 2916714-2021-00068
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083374
• UDI-Public: 4046955083374
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Device Lot Number: L50429911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1